I-Ning Tang | Senior Reviewer
Center For Drug Evaluation | Taiwan

I-Ning Tang, Senior Reviewer, Center For Drug Evaluation

Dr. Tang has worked as a medical reviewer since 2010, firstly in the Taiwan Food and Drug Administration (TFDA) and then in the Center for Drug Evaluation (CDE). TFDA is the competent authority in charge of food, drugs, controlled drugs, medical equipment and cosmetics related management in Taiwan; CDE was established by Department of Health (DOH, now Ministry of Health and Welfare, MOHW) in 1998, to assist the technical evaluation for market approval of drugs and medical devices. 

Dr. Tang received her M.D degree from the National Cheng Kung University, Taiwan, in 2001. After that she had practiced medicine for almost 10 years before entering the regulatory science field. She continued her education while working and received her master degree in 2010. Currently, she is a PhD candidate in the National Taiwan University (NTU), Taiwan, focusing on researches with respect to human brain networks on normal subjects and patients, and exploring possible surrogate endpoints from neuroimaging data.

Since joining the regulatory science filed, Dr. Tang has been involved in various projects. She is an experienced reviewer in evaluating market authorization application of both medical devices and drugs, also clinical trial protocols of all phases. A major part of her work at present is to provide scientific advices to domestic biotech companies, pharmaceutical companies, non-government organization and research institutes, assist government agencies such as the Ministry of Economic Affairs (MoEA) in evaluating biopharmaceutical industry development programs and budget, and give advices to government agencies for formulating policies and laws related to biopharmaceutical industry. In addition, she is frequently invited as a speaker in different specialized topics, like clinical trial protocol design, clinical trial regulations, adverse event reporting during clinical trials, etc.

Appearances:



Phar-East Day Two @ 11:10

Multi regional clinical trial (MRCT) harmonisation: An overview

This one hour session includes an overview presentation on MRCT in Asia, with quick 10-minute updates from Japan, Taiwan, Malaysia, Singapore and a combined 20 minutes panel session to discuss regulatory challenges from both regulator and pharma perspectives, successes so far and what can be expected in the year of 2020
 
11:00 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:10 Japan’s latest MRCT ICH guidelines
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:20 Taiwan
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
11:30 China
Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
 
11:40 Singapore
 
11:50 Panel: What successes have we achieved so far and how can we build a better synergy model to promote cross-country drug development?
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China

I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
Gloria Wang, Executive Director, Clinical Development, Just Biotherapeutics, China

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